Bruker unveils CE-marked SARS-CoV-2/Flu/RSV PCR kit in Europe 

21 December 2020 (Last Updated December 21st, 2020 14:39)

Bruker has announced the launch of a CE-marked FluoroType SARS-CoV-2/Flu/RSV winter four-plex PCR panel which can detect SARS-CoV-2 virus of influenza A and B viruses and respiratory syncytial virus (RSV) with high sensitivity.

Bruker unveils CE-marked SARS-CoV-2/Flu/RSV PCR kit in Europe 
FluoroType SARS-CoV-2/Flu/RSV panel is validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples. Credit: Bruker.

Bruker has announced the launch of a CE-marked FluoroType SARS-CoV-2/Flu/RSV winter four-plex PCR panel which can detect SARS-CoV-2 virus of influenza A and B viruses and respiratory syncytial virus (RSV) with high sensitivity.

Bruker noted that multiple viruses need to be differentiated in the winter season so a single assay will help in diagnosis as well as patient management.

The FluoroType SARS-CoV-2/Flu/RSV panel is validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples.

The kit has all reagents to generate up to 96 PCR result panels in two hours after nucleic acid extraction.

As per evaluations, 100% sensitivity and specificity were achieved with 112 nasopharyngeal or oropharyngeal swabs for all the viruses with very low limits of detection.

Furthermore, the winter four-plex panel is validated with an RNA extraction-free protocol on 60 saliva samples with a sensitivity of 100% and a specificity of 97.5%.

While saliva sample collection is convenient for patients, saliva PCR testing does not require extraction kit and will aid in providing reduced time-to-result and resource-effective for clinical labs.

Bruker Daltonics Microbiology & Diagnostics executive vice-president Dr Wolfgang Pusch said: “We appreciate the positive customer feedback on the performance of our new FluoroType SARS-CoV-2/Flu/RSV panel.

“Compared to PCR assays that detect only the SARS-CoV-2 virus, our winter four-plex panel offers added value in a cost-effective workflow.

“Our clinical laboratory customers now also have the option of offering the saliva workflow for patient convenience, faster time-to-result, and reduced resource requirements without RNA extraction.”

The panel can be used with the company’s high-precision FluoroCycler XT real-time PCR system or other real-time thermocyclers.

In addition, it is validated for use on Bruker´s GenoXtract (GXT) automated nucleic acid extraction devices with Bruker RNA extraction kits and Qiagen extraction chemistry, and for saliva workflow without RNA extraction.